EZETIMIBE - ezetimibe tablet 
Zydus Lifesciences Limited

----------

EZETIMIBE TABLETS

NDC 70771-1109-3 in bottle of 30 tablets

Ezetimibe Tablets , 10 mg

Rx only

30 tablets

Ezetimibe Tablets, 10 mg
EZETIMIBE 
ezetimibe tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1109
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24) EZETIMIBE10 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size9mm
FlavorImprint Code 773
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1109-330 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
2NDC:70771-1109-990 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
3NDC:70771-1109-1100 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
4NDC:70771-1109-5500 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
5NDC:70771-1109-01000 in 1 BOTTLE; Type 0: Not a Combination Product08/09/2017
6NDC:70771-1109-410 in 1 CARTON08/09/2017
6NDC:70771-1109-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20433108/09/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1109) , MANUFACTURE(70771-1109)

Revised: 8/2022
Document Id: 774be7a7-d346-44e5-9b48-c4cecb809064
Set id: de814dcd-4759-4e9c-a650-335fb885a79d
Version: 4
Effective Time: 20220826
 
Zydus Lifesciences Limited